PL Developments Receives FDA Approval for OTC Omeprazole Magnesium Tablet
PL Developments (PLD) has reached a major milestone with the FDA approval of its Omeprazole Magnesium Tablet, a product comparable to Prilosec® OTC. This achievement makes PLD the only provider of OTC Omeprazole manufactured in the United States, solidifying the company’s position as a leader in complex pharmaceutical manufacturing.
Bringing this product to market required several years of development, including bioequivalence (BE) studies and the application of Multi-Unit Pellet System (MUPS) technology, a highly advanced oral drug delivery system. This approval highlights PLD’s ability to develop, produce, and commercialize intricate pharmaceutical formulations that meet the rigorous standards of the U.S. healthcare market. PL Developments (PLD) has reached a major milestone with the FDA approval of its Omeprazole Magnesium Tablet, a product comparable to Prilosec® OTC. This achievement makes PLD the only provider of OTC Omeprazole manufactured in the United States,...
PL Developments (PLD) has reached a major milestone with the FDA approval of its Omeprazole Magnesium Tablet, a product comparable to Prilosec® OTC. This achievement makes PLD the only provider of OTC Omeprazole manufactured in the United States, solidifying the company’s position as a leader in complex pharmaceutical manufacturing.
Bringing this product to market required several years of development, including bioequivalence (BE) studies and the application of Multi-Unit Pellet System (MUPS) technology, a highly advanced oral drug delivery system. This approval highlights PLD’s ability to develop, produce, and commercialize intricate pharmaceutical formulations that meet the rigorous standards of the U.S. healthcare market.
Mastering Complexity: PLD’s Expertise in MUPS & Controlled-Release Technology
Omeprazole is notoriously difficult to manufacture due to its sensitivity to acid and moisture, requiring functional coating to protect the API. Additionally, compressing tablets on a tablet press is equally challenging as the pellets are prone to breaking during the compression process.
To bring this product to market, PLD leveraged its expertise in pelletized MUPS technology, a method that incorporates thousands of acid-resistant micropellets within a tablet, to optimize the release of omeprazole in the small intestine.
In addition to MUPS, PLD has invested in cutting-edge capabilities, including:
· Fluid bed coating, which expands PLD’s modified release capabilities.
· Advanced granulation techniques, which improve flowability, compressibility, and the uniformity of the final product, making it easier to produce consistent tablets, especially working with powders with poor compaction properties.
· GMP-compliant facilities, which ensures strict adherence to pharmaceutical quality standards.
PLD’s success at securing FDA approval for its OTC Omeprazole Magnesium tablet demonstrates the company’s commitment to innovation and technical excellence in developing difficult-to-manufacture products. Key to the company’s approach is utilizing PLD’s formulation and analytical labs, which have a long history of these types of complex formulation development projects and experience working with a wide variety of APIs.
While PLD does not currently manufacture high-potency drugs, the company is actively investing in the technology and equipment needed to further expand into modified-release oral solid and oral liquid markets. The FDA approval of Omeprazole represents just the beginning of PLD’s commitment to delivering advanced pharmaceutical solutions that meet evolving consumer and regulatory demands.
By pushing the boundaries of pharmaceutical innovation, PLD continues to strengthen its reputation as a trusted partner in the healthcare industry, capable of producing some of the most complex and challenging OTC medications on the market today. Learn more about how PLD can help you bring your product from concept to commercialization. Stop by PLD Pharma Services’s Booth #816 at CPhI NA to find out how we can put our experience and expertise to work for your next OTC or Rx product, or visit us online at www.pldpharma.com.
